News | October 24, 2007

Abiomed’s Safety Trial Meets Endpoints for High-Risk PCI

October 25, 2007 - Abiomed Inc. announced for the first time, at TCT 2007, that the Impella 2.5 PROTECT I safety trial for patients with high-risk PCI met all primary and secondary endpoints and showed very low adverse event rates.

PROTECT I is the first prospective multi-center, FDA-approved trial for prophylactic, or preventative, use of a device during high-risk percutaneous coronary intervention (PCI) procedures. The 20 patient pilot study with the Impella 2.5 met all primary and secondary endpoints and showed very low adverse event rates in a very sick patient population. The results demonstrated no incidents of: aortic valve damage, aortic or mitral dysfunction, sepsis, stroke, thromboembolic events, vascular complications, insertion-site infection, device malfunction, device-related bleeding, limb ischemia or clinical issues with hemolysis.

“We are pleased to release the successful results of the safety trial at TCT and are excited to begin the pivotal study with an expanded patient population including high-risk PCI with triple vessel disease for patients at up to 150 centers,” said Michael R. Minogue, chairman, CEO and President of Abiomed. “Experience with the Impella 2.5 in the safety trial and in multiple studies in Europe under CE-Mark provides significant evidence of the clinical benefit to patients, and we continue to work with the FDA to bring this breakthrough technology to the U.S.”

“In the PROTECT I pilot trial, Impella delivered supreme protection and support. It enabled success in procedures that would have been otherwise impossible,” said J.P.S. Henriques, M.D., Cardiologist at the Academic Medical Center in Amsterdam.

Dr. Laura Mauri of Brigham & Women’s Hospital also presented new data from the completed PROTECT I trial: “Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk PCI.” An independent Core Lab analysis completed at Duke University determined no damage to the septum, heart chambers, or mitral/aortic valves. At a 30-day follow-up, patients enrolled in the PROTECT I trial showed an improvement of their heart function demonstrated by an absolute increase of 7 percent in their left ventricular ejection fraction, equating to a 27 percent relative increase.

“We have been impressed by the ease-of-use and high safety profile of the Impella 2.5 technology during the PROTECT I pilot trial,” said William O'Neill, M.D., national principal investigator for the pilot and pivotal studies of the Impella 2.5, and professor and executive dean for Clinical Affairs, Division of Cardiology at the Leonard M. Miller School of Medicine at the University of Miami. “With an aging population, Impella will have a significant role in the treatment of high-risk patients, so we are excited to further demonstrate its effectiveness in the recently approved pivotal trial.”

For more information: www.abiomed.com

Related Content

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Overlay Init